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Completed

NCT Number: NCT07217106

A Study of Accelerated Guideline-Directed Medical Therapy for Heart Failure

The aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). For the comparator arm, patients in the GDMT clinic were matched to data of patients contained within in the MGH Research Patient Data Repository (RPDR).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of HF, including new onset disease
  • Established cardiovascular follow up at the hospital
  • Received sub-optimal medical care defined as <50% target doses of GDMT agents
  • Left ventricular ejection fraction (LVEF) <50%

Exclusion criteria

  • Planned referral to the Advanced HF program
  • Decompensated HF
  • End-stage kidney disease

o glomerular filtration rate (GFR) <15 mL/min/1.73m^2 or on renal replacement therapy

  • Untreated severe valvular heart disease
  • Advanced HF
  • Inotropic support
  • Transplant or mechanical circulatory support (MCS) planned
  • Enrolled in hospice or palliative care
  • Life expectancy <12 months due to non-cardiovascular (CV) disease
  • Pericardial constriction
  • Hypertrophic cardiomyopathy
  • Unwillingness or inability to take GDMT
  • Pregnancy or breast feeding

Treatment and study plan

Primary outcomes

  1. Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up

    Time frame: Up to approximately 16 weeks

    Class I GDMT drugs included angiotensin receptor/neprilysin inhibitor (ARNI), evidence-based beta blocker (eBBB), mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter-2 inhibitor (SGLT2i) or renin angiotensin system inhibitor (RASi), eBBB, MRA, SGLT2i.

Secondary outcomes

  1. Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up

    Time frame: Up to approximately 16 weeks

  2. Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline

    Time frame: Baseline and up to approximately 16 weeks

  3. Change From Baseline in New York Heart Association (NYHA) Classification

    Time frame: Baseline and up to approximately 16 weeks

    The NYHA classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:

    Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.

    Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.

    Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.

    Class IV - Unable to carry out any physical activity without symptoms of HF, or symptoms of HF at rest.

  4. Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration

    Time frame: Baseline and up to approximately 16 weeks

  5. Change From Baseline in Echocardiography Measurement: LVEF

    Time frame: Baseline and up to approximately 16 weeks

  6. Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi)

    Time frame: Baseline and up to approximately 16 weeks

  7. Change From Baseline in Echocardiography Measurement: Left Ventricular End-Systolic Volume Index (LVESVi)

    Time frame: Baseline and up to approximately 16 weeks

  8. Change From Baseline in Echocardiography Measurement: Left Atrial Volume Index (LAVi)

    Time frame: Baseline and up to approximately 16 weeks

  9. Change From Baseline in Echocardiography Measurement: Left Ventricular Mass Index (LVMi)

    Time frame: Baseline and up to approximately 16 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Retrospective Assessment of Accelerated Guideline-Directed Medical Therapy for Heart Failure

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2025
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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